Analyte-testing device

ABSTRACT

A device adapted to determine an analyte concentration of a fluid sample using a test sensor. The device comprises a display adapted to display information to a user. The device further comprises at least one user-interface mechanism adapted to allow the user to interact with the device. The device further comprises a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor. The device further comprises a memory adapted to store a plurality of stored analyte concentrations. The device further comprises a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.

FIELD OF THE INVENTION

The present invention relates generally to an analyte-testing deviceand, more particularly, to a meter adapted to limit the analyteconcentrations that are viewable during testing and a method ofperforming the same.

BACKGROUND OF THE INVENTION

The quantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalabnormalities. For example, lactate, cholesterol, and bilirubin shouldbe monitored in certain individuals. In particular, determining glucosein body fluids is important to diabetic individuals who must frequentlycheck the glucose level in their body fluids to regulate the glucoseintake in their diets. The results of such tests may be used todetermine what, if any, insulin and/or other medication needs to beadministered. In one type of testing system, test sensors are used totest a fluid such as a sample of blood.

One method of monitoring an individual's blood glucose level is with aportable, hand-held blood glucose testing device (e.g., a meter). Todetermine the blood glucose level with the meter, a lancet device may beused with a needle lancet that pierces the skin tissue and allows awhole blood sample to form on the skin's surface. Once the requisiteamount of blood forms on the skin's surface, the blood sample istransferred to a test sensor. The test sensor is generally placed in anopening in the body of the meter.

Existing meters typically include a memory for storing previous analyteconcentrations taken at earlier times. The stored test results aregenerally stored within the memory until they are transferred to anotherdevice having a larger memory (e.g., a computer) or deleted.Furthermore, meters generally include a scroll button or other type ofuser-interface mechanism that allows a user to review stored testresults.

A problem occurs when the stored test results are accidentally accessedby the user (e.g., by accidentally pressing the scroll button). Forexample, a user testing his or her glucose concentration mayaccidentally and/or unknowingly press the scroll button during testing,thereby causing the user to mistake a glucose concentration associatedwith a previous testing procedure for the user's current glucoseconcentration. Such mistaken test results may result in unsafe glucoselevels (e.g., hyperglycemic or hypoglycemic conditions) beingundetected, which may be dangerous for a user and may have serioushealth-related consequences.

It would be desirable to provide an analyte-testing device that assistsin addressing the above disadvantages.

SUMMARY OF THE INVENTION

According to one embodiment, a device adapted to determine an analyteconcentration of a fluid sample using a test sensor is disclosed. Thedevice comprises a display adapted to display information to a user. Thedevice further comprises at least one user-interface mechanism adaptedto allow the user to interact with the device. The device furthercomprises a body portion including at least one opening formed therein.The at least one opening is of sufficient size to receive the testsensor. The device further comprises a memory adapted to store aplurality of stored analyte concentrations. The device further comprisesa processing feature adapted to inhibit the stored analyteconcentrations from being displayed on the display.

According to another embodiment, a device adapted to determine ananalyte concentration of a fluid sample using a test sensor isdisclosed. The device comprises a display adapted to display informationto a user. The device further comprises at least one user-interfacemechanism for allowing the user to interact with the device. The devicefurther comprises a body portion including at least one opening formedtherein. The at least one opening is adapted to receive a test sensor.The device further comprises a memory adapted to store a plurality ofstored analyte concentrations. When the at least one opening includes atest sensor, the display is limited to displaying only informationassociated with a current analyte concentration.

According to one process, a method of using a device adapted todetermine an analyte concentration of a fluid sample using a test sensoris disclosed. The method comprises the act of providing a devicecomprising a display, at least one user-interface mechanism, a bodyportion including at least one opening formed therein, and a memoryadapted to store a plurality of stored analyte concentrations. Themethod further comprises the act of interacting with the at least oneuser-interface mechanism. The at least one user-interface mechanism isadapted to assist in displaying at least one of the plurality of storedanalyte concentrations on the display. The method further comprises theact of determining whether a predetermined condition exists. The methodfurther comprises the act of, if the predetermined condition exists,inhibiting the plurality of stored analyte concentrations from beingdisplayed on the display.

According to another process, a method of using a device adapted todetermine an analyte concentration of a fluid sample using a test sensoris disclosed. The method comprises the act of providing a devicecomprising a display, at least one user-interface mechanism, a bodyportion including at least one opening formed therein, and a memoryadapted to store a plurality of stored analyte concentrations. Themethod further comprises the act of interacting with the at least oneuser-interface mechanism. The at least one user-interface mechanism isadapted to assist in displaying at least one of the plurality of storedanalyte concentrations on the display. The method further comprises theact of determining whether a test sensor is positioned in the at leastone opening. The method further comprises the act of, if a test sensoris positioned in the at least one opening, inhibiting the plurality ofstored analyte concentrations from being displayed on the display.

The above summary of the present invention is not intended to representeach embodiment or every aspect of the present invention. Additionalfeatures and benefits of the present invention are apparent from thedetailed description and figures set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a meter according to one embodiment.

FIG. 2 is a flow diagram detailing one method of the present invention.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The embodiments of the present invention are directed to ananalyte-testing device, or meter, having a display-inhibiting feature.More specifically, the meters of the embodiments described hereininhibit or prevent a user from accidentally and/or unknowingly viewingstored analyte concentrations from previous analyte-testing procedures.

The meters described herein may be used to assist in determining ananalyte concentration in a fluid sample. Some examples of the types ofanalytes that may be collected and analyzed include glucose, lipidprofiles (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin,hemoglobin, A_(1C), fructose, lactate, or bilirubin. The presentinvention is not limited, however, to these specific analytes, and it iscontemplated that other analyte concentrations may be determined. Theanalytes may be in, for example, a whole blood sample, a blood serumsample, a blood plasma sample, or other body fluids like interstitialfluid (ISF) and/or urine. One non-limiting example of a use for thetest-sensor cartridge and meter is to determine the glucoseconcentration in a user's blood, plasma, or ISF.

FIG. 1 illustrates a meter 10 according to one embodiment. The meter 10includes a display 12, a body portion 14, at least one test-sensoropening, at least one user-interface mechanism 18 for allowing a user tointeract with the meter 10, and a processor 26 adapted to processinformation. The at least one test-sensor opening includes an opening 16adapted to receive and/or hold a test sensor. The at least one openingmay also be adapted to dispense a test sensor. In the illustratedembodiment, the user-interface mechanism 18 includes a plurality ofbuttons 18 a-c. It is contemplated that the user-interface may includeother mechanisms suitable for communicating with the meter 10 including,but not limited to, a scroll wheel, touch screens, or combinationsthereof. Although the embodiments described herein are generallydescribed as having one or more buttons 18 a-c as the user-interfacemechanism, any suitable type of user-interface mechanism or combinationsthereof may be used instead of the buttons 18 a-c described herein. Oneexample of a display 12 that may be used in the meter 10 is aliquid-crystal display. The display 12 typically shows informationregarding a testing procedure and/or information in response to signalsinput by the user-interface mechanism (e.g., buttons 18 a-c). The resultof the testing may also be announced audibly, by, for example, using aspeaker. The meter 10 may then store the information in a memory 19.

After the testing has been completed, the test sensor may be removedfrom the opening 16 using one of several methods. In one embodiment, themeter 10 may include an eject mechanism 20 that ejects the used testsensor from the meter 10. In such an embodiment, the test sensor isreleased forcefully. In a further embodiment, the test sensor may beremoved manually from the meter 10.

The memory 19 generally stores information associated with previousanalyte-testing procedures. For example, the memory 19 may includeprevious analyte concentrations, the date and time at which the previoustests were performed, other information associated with the previoustests, combinations thereof, or the like. A user may access stored testresults from the memory 19 by interacting with the user interfacemechanism 18 a-c. For example, the user may press a scroll button 18 bto scroll through stored test results stored in the memory 19 of themeter 10. The user may link the meter 10 to another device (e.g., acomputer 21) having a larger memory to copy or transfer the data to theother device. The data may be transferred using a cable 22, wirelessly,or using any other suitable means. In one embodiment, for example, themeter 10 is used with a continuous analyte monitoring assembly, whichmay be connected to a remote-monitoring system over a communicationslink.

The meters of the embodiments described herein include adisplay-inhibiting feature adapted to inhibit or prevent stored analyteconcentrations from previous analyte-testing procedures from beingdisplayed on the display. The display-inhibiting feature thus inhibitsor prevents a user from accidentally and/or unknowingly causing storedtest results to be displayed on the display. The display-inhibitingfeature may, for example, be a processing feature. Thedisplay-inhibiting feature may be accomplished using software within themeter 10, hardware, or a combination thereof. For example, the featuremay be associated with the processor 26.

According to one embodiment, the display-inhibiting feature isselectively activated during specific instances. For example, in oneembodiment, the display-inhibiting feature is activated when a testsensor is positioned within the opening 16. Thus, when a test sensor ispositioned within the opening 16, the display 12 is limited todisplaying only information associated with the current analyte-testingprocedure (e.g., the present analyte concentration, the present dateand/or time, combinations thereof, or the like). The meter 10 mayinclude a detector 24, a switch, or the like positioned proximate to theopening 16 that detects when a test sensor is positioned within theopening 16. It is contemplated that the display-inhibiting feature maybe deactivated (e.g., information regarding stored analyteconcentrations may be viewed) upon removal of the test sensor from theopening 16. Activating the display-inhibiting feature during testingprocedures may be beneficial to inhibit or prevent the user fromaccidentally interacting with the user-interface mechanism (e.g.,pressing the scroll button 18 b), causing information associated with aprevious testing procedure to appear on the screen, and mistaking astored analyte concentration for the user's current analyteconcentration.

Turning now to FIG. 2, a flow diagram is shown according to one methodof the present invention. At act 102, a user interacts with auser-interface mechanism (e.g., a scroll button 18 b) positioned on themeter 10 to view stored analyte concentrations and informationassociated therewith. At act 104, the meter 10 determines whether apredetermined condition exists. One non-limiting example of apredetermined condition includes a test sensor being positioned withinthe opening 16. If at act 104, the meter 10 determines that thepredetermined condition(s) exists (e.g., a test sensor is positionedwithin the opening 16), the stored analyte concentrations are inhibitedfrom being displayed on the display 12 at act 106. In one embodiment,the user may receive an audible message or a message on the display 12indicating that the scroll button 18 b was pressed, that stored testresults may not be viewed during a testing procedure, a combinationthereof, or the like. Upon removing the sensor from the opening 16, thestored analyte concentrations may be displayed on the display 12. If, onthe other hand, the meter 10 determines at act 104 that thepredetermined condition(s) does not exist (e.g., a test sensor is notpositioned within the opening 16), the meter 10 may display storedanalyte concentrations at act 108.

According to another embodiment, the display-inhibiting feature iscontinuously activated such that one or more predetermined, affirmativeacts must be performed each time a user desires to view stored analyteconcentrations to override the display-inhibiting feature. In onenon-limiting example, pressing the scroll button 18 b may cause themeter 10 to prompt the user to press another button(s), to repress thescroll button 18 b, to press and hold a button 18 a-c, to press two ormore buttons 18 a-c simultaneously, or to perform some other affirmativeact(s) to confirm that the user desires to view stored test results andthat the scroll button 18 b was not pressed accidentally. The meter 10may prompt the user to perform such an affirmative act(s) by displayinginstructions on the display 12, by audibly instructing the user, acombination thereof, or the like. The ability to override thedisplay-inhibiting feature may be applied to meters in which thedisplay-inhibiting feature is continuously activated or to meters inwhich the display-inhibiting feature is selectively activated (e.g.,when a test sensor is positioned within the opening 16, as describedabove). It is contemplated that types of analyte-testing devices otherthan the meter 10 shown in FIG. 1 may be used in conjunction with any ofthe embodiments described herein.

Alternative Embodiment A

A device adapted to determine an analyte concentration of a fluid sampleusing a test sensor, the device comprising:

a display adapted to display information to a user;

at least one user-interface mechanism adapted to allow the user tointeract with the device;

a body portion including at least one opening formed therein, the atleast one opening being of sufficient size to receive the test sensor;

a memory adapted to store a plurality of stored analyte concentrations;and

a processing feature adapted to inhibit the stored analyteconcentrations from being displayed on the display.

Alternative Embodiment B

The device of Alternative Embodiment A, wherein the processing featureis continuously activated.

Alternative Embodiment C

The device of Alternative Embodiment A, wherein the processing featureis selectively activated.

Alternative Embodiment D

The device of Alternative Embodiment C, wherein the processing featureis activated when the at least one opening includes a test sensor.

Alternative Embodiment E

The device of Alternative Embodiment D, wherein the processing featureincludes a detector proximate to the at least one opening, the detectorbeing adapted to detect whether the at least one opening includes a testsensor.

Alternative Embodiment F

The device of Alternative Embodiment D, wherein the processing featureis adapted to deactivate the at least one user-interface mechanism.

Alternative Embodiment G

The device of Alternative Embodiment A, wherein when the processingfeature is activated, the display is limited to displaying informationassociated with a current analyte concentration.

Alternative Embodiment H

The device of Alternative Embodiment A, wherein the processing featuremay be overridden by interacting with the at least one user-interfacemechanism in a predetermined manner.

Alternative Embodiment I

A device adapted to determine an analyte concentration of a fluid sampleusing a test sensor, the device comprising:

a display adapted to display information to a user;

at least one user-interface mechanism for allowing the user to interactwith the device;

a body portion including at least one opening formed therein, the atleast one opening being adapted to receive a test sensor; and

a memory adapted to store a plurality of stored analyte concentrations,

wherein when the at least one opening includes a test sensor, thedisplay is limited to displaying only information associated with acurrent analyte concentration.

Alternative Embodiment J

The device of Alternative Embodiment I, wherein upon removal of the testsensor from the at least one opening, information associated with storedanalyte concentrations may be viewed.

Alternative Embodiment K

The device of Alternative Embodiment I, further including a hardwarecomponent adapted to limit the information displayed on the display.

Alternative Embodiment L

The device of Alternative Embodiment K, further comprising a detectorproximate to the at least one opening, the detector being adapted todetect whether the at least one opening includes a test sensor.

Alternative Embodiment M

The device of Alternative Embodiment I, further including a softwarecomponent adapted to limit the information displayed on the display.

Alternative Process N

A method of using a device adapted to determine an analyte concentrationof a fluid sample using a test sensor, the method comprising the actsof:

providing a device comprising a display, at least one user-interfacemechanism, a body portion including at least one opening formed therein,and a memory adapted to store a plurality of stored analyteconcentrations;

interacting with the at least one user-interface mechanism, the at leastone user-interface mechanism being adapted to assist in displaying atleast one of the plurality of stored analyte concentrations on thedisplay;

determining whether a predetermined condition exists; and

if the predetermined condition exists, inhibiting the plurality ofstored analyte concentrations from being displayed on the display.

Alternative Process O

The method of Alternative Process N, further comprising the act of, ifthe predetermined condition does not exist, displaying the at least oneof the plurality of stored analyte concentrations on the display.

Alternative Process P

The method of Alternative Process N, wherein the predetermined conditionincludes a test sensor being positioned in the at least one opening.

Alternative Process Q

The method of Alternative Process N, wherein the device further includesa software component adapted to inhibit the plurality of stored analyteconcentrations from being displayed on the display.

Alternative Process R

The method of Alternative Process N, wherein act of the inhibiting theplurality of stored analyte concentrations from being displayed on thedisplay includes deactivating the user-interface mechanism.

Alternative Process S

The method of Alternative Process N, further comprising performing apredetermined act, the predetermined act assisting in displaying atleast one of the plurality of stored analyte concentrations on thedisplay.

Alternative Process T

A method of using a device adapted to determine an analyte concentrationof a fluid sample using a test sensor, the method comprising the actsof:

providing a device comprising a display, at least one user-interfacemechanism, a body portion including at least one opening formed therein,and a memory adapted to store a plurality of stored analyteconcentrations;

interacting with the at least one user-interface mechanism, the at leastone user-interface mechanism being adapted to assist in displaying atleast one of the plurality of stored analyte concentrations on thedisplay;

determining whether a test sensor is positioned in the at least oneopening; and

if a test sensor is positioned in the at least one opening, inhibitingthe plurality of stored analyte concentrations from being displayed onthe display.

Alternative Process U

The method of Alternative Process T, further comprising the act of, if atest sensor is not positioned in the at least one opening, displaying atleast one of the plurality of stored analyte concentrations on thedisplay.

Alternative Process V

The method of Alternative Process T, further comprising the act of, uponremoving the test sensor from the at least one opening, allowing theplurality of stored analyte concentrations to be displayed on thedisplay.

Alternative Process W

The method of Alternative Process T, wherein the device further includesa software component adapted to inhibit the plurality of stored analyteconcentrations from being displayed on the display.

Alternative Process X

The method of Alternative Process T, wherein the device further includesa detector positioned proximate to the at least one opening.

Alternative Process Y

The method of Alternative Process X, wherein the act of determiningwhether a test sensor is positioned in the at least one opening includesthe detector detecting that the test sensor is positioned in the atleast one opening.

While the invention is susceptible to various modifications andalternative forms, specific embodiments are shown by way of example inthe drawings and are described in detail herein. It should beunderstood, however, that the invention is not intended to be limited tothe particular forms disclosed. Rather, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the invention as defined by the appended claims.

1. A device adapted to determine an analyte concentration of a fluid sample using a test sensor, the device comprising: a display adapted to display information to a user; at least one user-interface mechanism adapted to allow the user to interact with the device; a body portion including at least one opening formed therein, the at least one opening being of sufficient size to receive the test sensor; a memory adapted to store a plurality of stored analyte concentrations; and a processing feature adapted to inhibit the stored analyte concentrations from being displayed on the display.
 2. The device of claim 1, wherein the processing feature is continuously activated.
 3. The device of claim 1, wherein the processing feature is selectively activated.
 4. The device of claim 3, wherein the processing feature is activated when the at least one opening includes a test sensor.
 5. The device of claim 4, wherein the processing feature includes a detector proximate to the at least one opening, the detector being adapted to detect whether the at least one opening includes a test sensor.
 6. The device of claim 4, wherein the processing feature is adapted to deactivate the at least one user-interface mechanism.
 7. The device of claim 1, wherein when the processing feature is activated, the display is limited to displaying information associated with a current analyte concentration.
 8. The device of claim 1, wherein the processing feature may be overridden by interacting with the at least one user-interface mechanism in a predetermined manner.
 9. A device adapted to determine an analyte concentration of a fluid sample using a test sensor, the device comprising: a display adapted to display information to a user; at least one user-interface mechanism for allowing the user to interact with the device; a body portion including at least one opening formed therein, the at least one opening being adapted to receive a test sensor; and a memory adapted to store a plurality of stored analyte concentrations, wherein when the at least one opening includes a test sensor, the display is limited to displaying only information associated with a current analyte concentration.
 10. The device of claim 9, wherein upon removal of the test sensor from the at least one opening, information associated with stored analyte concentrations may be viewed.
 11. The device of claim 9, further including a hardware component adapted to limit the information displayed on the display.
 12. The device of claim 11, further comprising a detector proximate to the at least one opening, the detector being adapted to detect whether the at least one opening includes a test sensor.
 13. The device of claim 9, further including a software component adapted to limit the information displayed on the display.
 14. A method of using a device adapted to determine an analyte concentration of a fluid sample using a test sensor, the method comprising the acts of: providing a device comprising a display, at least one user-interface mechanism, a body portion including at least one opening formed therein, and a memory adapted to store a plurality of stored analyte concentrations; interacting with the at least one user-interface mechanism, the at least one user-interface mechanism being adapted to assist in displaying at least one of the plurality of stored analyte concentrations on the display; determining whether a predetermined condition exists; and if the predetermined condition exists, inhibiting the plurality of stored analyte concentrations from being displayed on the display.
 15. The method of claim 14, further comprising the act of, if the predetermined condition does not exist, displaying the at least one of the plurality of stored analyte concentrations on the display.
 16. The method of claim 14, wherein the predetermined condition includes a test sensor being positioned in the at least one opening.
 17. The method of claim 14, wherein the device further includes a software component adapted to inhibit the plurality of stored analyte concentrations from being displayed on the display.
 18. The method of claim 14, wherein act of the inhibiting the plurality of stored analyte concentrations from being displayed on the display includes deactivating the user-interface mechanism.
 19. The method of claim 14, further comprising performing a predetermined act, the predetermined act assisting in displaying at least one of the plurality of stored analyte concentrations on the display.
 20. A method of using a device adapted to determine an analyte concentration of a fluid sample using a test sensor, the method comprising the acts of: providing a device comprising a display, at least one user-interface mechanism, a body portion including at least one opening formed therein, and a memory adapted to store a plurality of stored analyte concentrations; interacting with the at least one user-interface mechanism, the at least one user-interface mechanism being adapted to assist in displaying at least one of the plurality of stored analyte concentrations on the display; determining whether a test sensor is positioned in the at least one opening; and if a test sensor is positioned in the at least one opening, inhibiting the plurality of stored analyte concentrations from being displayed on the display.
 21. The method of claim 20, further comprising the act of, if a test sensor is not positioned in the at least one opening, displaying at least one of the plurality of stored analyte concentrations on the display.
 22. The method of claim 20, further comprising the act of, upon removing the test sensor from the at least one opening, allowing the plurality of stored analyte concentrations to be displayed on the display.
 23. The method of claim 20, wherein the device further includes a software component adapted to inhibit the plurality of stored analyte concentrations from being displayed on the display.
 24. The method of claim 20, wherein the device further includes a detector positioned proximate to the at least one opening.
 25. The method of claim 24, wherein the act of determining whether a test sensor is positioned in the at least one opening includes the detector detecting that the test sensor is positioned in the at least one opening. 